Page 157 - CW E-Magazine (3-12-2024)

Pharmaceuticals

REGULATORY ACTION
Lupin, Dr. Reddy’s recall drugs in US: USFDA

Lupin is recalling over six lakh The affected lot is manufactured medically reversible adverse health
bottles of a medication indicated for at Lupin’s Goa-based manufacturing consequences or where the probability
high blood pressure in the US due to facility, it stated. The company is re- of serious adverse health consequences
deviation from current good manufac- calling 1,12,770 bottles of 2.5-mg tab- is remote.
turing practices (cGMP), according to lets; 1,46,322 bottles of 5-mg tablets
the US health regulator. and 3,57,414 bottles of 10-mg tablets, In a separate listing, USFDA stated
it said. that a US-based unit of Dr. Reddy’s Labo-
As per its latest Enforcement ratories is recalling 3,416 India-made
Report, US Food and Drug Administra- The US health regulator noted that bottles of IBU (ibuprofen) 600-mg
tion (USFDA), stated that Dr. Reddy’s the company is undertaking Class II tablets in the US. Princeton (NJ) based
Laboratories is also recalling a prod- voluntary recall due to “cGMP Devia- Dr. Reddy’s Laboratories, Inc, initiated
uct in the US due to a manufacturing tions: Active pharmaceutical ingredient the Class III recall due to “failed tablet/
issue. was sourced from an unapproved vendor.” capsule specifi cations,” USFDA said.
Lupin Pharmaceuticals Inc. initiated the
Baltimore-based Lupin Pharma- recall on October 23 this year. The company initiated the voluntary
ceuticals Inc., a subsidiary of Mumbai- recall on October 29. As per the USFDA,
based Lupin, is recalling 6,16,506 As per the USFDA, a Class II re- a Class III recall is initiated in a “situ-
bottles of ‘Ramipril’ capsules in call is initiated in a situation in which ation in which use of, or exposure to, a
strengths of 2.5-mg, 5-mg and 10-mg, the use of, or exposure to, a viola- violative product is not likely to cause
the US health regulator said. tive product may cause temporary or adverse health consequences.”
Pharma sector’s strong Q2 growth driven by

North American market: Report

Major pharmaceutical companies the India business (9.8 percent YoY),” overall market. The healthcare sector
of the country reported a 10 per- the report said. also showed impressive growth
cent year-on-year (YoY) growth in in Q2FY25, with top-line revenue
the second quarter of FY25, largely The report also outlined a positive increasing by 17.6 percent YoY and
driven by strong performance in outlook for the pharmaceutical sector 10.4 percent quarter-on-quarter (QoQ).
North America and the domestic over the next three years, with a
market, according to a report by Axis healthy pipeline expected in biosimi- Improved hospital occupancy
Securities. lars, GLP-1, and peptides. Companies rates, which rose by 340 basis points
with a signifi cant share of chronic (bps) YoY and 470 bps QoQ, were a
As per the report, the Indian Pharma- portfolios continue to outperform the key growth driver.
ceutical Market (IPM) grew by 8
percent YoY, with chronic therapies Dr. Reddy’s API unit gets Form 483 from
showing a 9 percent increase. However, USFDA
acute therapies experienced modest
growth of 4 percent due to a weak Dr. Reddy’s Laboratories’ API faci- tion from November 13 to 19, 2024. At
season for these segments. lity in Bollaram, Hyderabad, received a the conclusion of the inspection, the
Form 483 with seven observations after USFDA presented the Form 483 outlin-
“The pharmaceutical universe under a USFDA inspection. ing potential violations.
our coverage reported Q2FY25 growth
of 10.2 percent YoY and 1.7 percent The US Food & Drug Administra- The company has committed to re-
QoQ, driven by robust growth in tion (USFDA) carried out the Good solving the issues within the stipulated
North America (10.8 percent YoY) and Manufacturing Practice (GMP) inspec- timeline set by the regulatory body.

Chemical Weekly December 3, 2024 157

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